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Myocardial InfarctionPhase 2TETHYSNCT01741558

The Effects of mETHotrexate Therapy on ST Segment Elevation MYocardial InfarctionS (TETHYS Trial)

A Phase 2 study testing Methotrexate and Riboflavin in people with Myocardial Infarction, run by Instituto de Cardiologia do Rio Grande do Sul at 2 sites in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Experimental studies suggest that anti-inflammatory and immunomodulatory drugs could reduce the inflammatory profile in acute ischemic disease and reduce the area of ischemia. Methotrexate is a drug that has shown promise in ischemic disease in animal studies. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myocardial Infarction
What is being tested?
Methotrexate and Riboflavin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
2 sitesBrazil
Study dates
Apr 2013to Dec 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age over 18 years;
  • Chest pain suggestive of acute myocardial infarction initiated within 12 hours;
  • Electrocardiogram with ST-segment elevation greater than or equal to 0.2 mV in at least 2 contiguous leads;
  • Choice of primary angioplasty

Who cannot join

  • Prior acute myocardial infarction;
  • Prior heart failure;
  • Angioplasty in the last 3 months;
  • Cardiac arrest or cardiogenic shock;
  • History of renal insufficiency (serum creatinine greater than 2.0 mg/dl);
  • History of alcohol abuse (consumption equal to or greater than 20 drinks per week);
Show all 15Show fewer
  • Illicit drug use;
  • Evidence of rheumatoid arthritis;
  • Neoplasia;
  • Infectious diseases;
  • Prior anemia (hematocrit below 30%);
  • Use of anti-inflammatory hormonal or non-hormonal last week;
  • Xanthines excessive consumption (more than two and a half cups of coffee or two and a half mate gourds);
  • Pregnancy;
  • Disagreement with the term of consent;

Trial locations and contacts

2 sites in 1 country.

Daniel M. Moreira, MSc. contact

554884175590

danielmedeirosmoreira@gmail.com

Brazil2 sites

  • Instituto de Cardiologia do Rio Grande do Sul / Fundação Universitária de Cardiologia

    Porto Alegre, Rio Grande do Sul, 90620001

    Daniel M. Moreira, MD. MSc., 554884175590, danielmedeirosmoreira@gmail.com

    Daniel M. Moreira, MD. MSc.

  • Instituto de Cardiologia de Santa Catarina

    São José, Santa Catarina, 88103901

    Daniel M. Moreira, MD. MSc, 554884175590, danielmedeirosmoreira@gmail.com

    Maria E. Lueneberg, MD.

Other trials in Brazil

About this study

Official title: The Effects of mETHotrexate Therapy on ST Segment Elevation MYocardial InfarctionS: Randomized Double-blind, Placebo-controlled Trial (TETHYS Trial)

Experimental studies suggest that anti-inflammatory and immunomodulatory drugs could reduce the inflammatory profile in acute ischemic disease and reduce the area of ischemia. Methotrexate is a drug that has shown promise in ischemic disease in animal studies.

Read the detailed description

Atherosclerosis and ischemic disease have clear association with inflammation. There is an anti-inflammatory action of methotrexate by increasing adenosine. Experimental studies demonstrate reduction of infarct induced in animals treated with methotrexate. We expect a reduction in the area under the curve of creatine kinase (CK), creatine kinase MB fraction (CK-MB) and Troponin I high sensitive, decreased levels of B-type natriuretic peptide (BNP) and improvement in left ventricular ejection fraction.

Being tested
Methotrexate, Riboflavin
Keywords
Myocardial Ischemia, Myocardial Infarction, Methotrexate, Inflammation, Anti-Inflammatory Agents, Inflammation Mediators
Medical subject headings
Myocardial Infarction, Myocardial Ischemia, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MethotrexateDrug

    Also called Rheumatrex®, Trexall®, Amethopterin, MTX

    The treatment group will receive a bolus dose of 0.05 mg/kg of methotrexate before primary angioplasty followed by 0.05 mg/kg per hour for 6 hours

  • RiboflavinDrug

    We use riboflavin in placebo group to remain the double-blind fashion: methotrexate has a yellow color and riboflavin in that concentration has the same color.

Study groups in NCT01741558
Study groupRoleWhat they receive
MethotrexateExperimentalEstablished treatment associated with methotrexate
Receives: Drug: Methotrexate
Placebo (Riboflavin)Placebo comparatorEstablished treatment associated with placebo (riboflavin sodium fosfate 0.1%). We use riboflavin in placebo group to remain the double-blind fashion: methotrexate has a yellow color and riboflavin in that concentration has the same color.
Receives: Drug: Riboflavin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area under the curve of creatine kinase

    The primary end point was the reduction of the size of the infarct as assessed by the area under the curve (AUC) (expressed in arbitrary units) for creatine kinase (CK) during 72 hours after the infarct

    Measured: During 72 hours after the infarct

Secondary outcomes (11)

  1. Area under the curve for creatine kinase MB fraction and troponin I high sensitive

    The primary end point was the reduction of the size of the infarct as assessed by the area under the curve (AUC) (expressed in arbitrary units) for creatine kinase MB fraction(CK-MB) and Troponin I high sensitive during 72 hours after the infarct

    Measured: During 72 hours after the infarct

  2. Compare the peaks of CK, CK-MB and troponin I ultra-sensitive

    Compare the peaks of CK, CK-MB and troponin I ultra-sensitive

    Measured: During 72 hours after the infarct

  3. Compare the levels of high-sensitivity C-reactive protein at admission, after 72 hours and after 3 months

    Compare the levels of high-sensitivity C-reactive at admission, after 72 hours and after 3 months

    Measured: After 72 hours and after 3 months

  4. Compare the levels of erythrocyte sedimentation rate on admission and after 72 hours

    Compare the levels of erythrocyte sedimentation rate on admission and after 72 hours

    Measured: On admission and after 72 hours

  5. Compare B-type natriuretic peptide (BNP) levels on admission, after 72 hours and after 3 months

    Compare B-type natriuretic peptide (BNP) levels on admission, after 72 hours and after 3 months

    Measured: On admission, after 72 hours and after 3 months

  6. Compare the "TIMI frame count" of the culprit artery

    Compare the "TIMI frame count" of the culprit artery

    Measured: On admission

  7. Compare the Killip score on admission and after 72 hours

    Compare the Killip score on admission and after 72 hours;

    Measured: On admission and after 72 hours

  8. Assess ventricular ejection fraction with transthoracic echocardiography during the first 72 hours after 3 months

    Assess ventricular ejection fraction with transthoracic echocardiography during the first 72 hours after 3 months

    Measured: During the first 72 hours after 3 months

  9. Assess mortality at 3 months

    Assess mortality at 3 months;

    Measured: At 3 months;

  10. Evaluate reinfarction in 3 months

    Evaluate reinfarction in 3 months

    Measured: In 3 months

  11. Rate side effects

    Evaluation in 72 hours the changes in the levels of hematocrit, hemoglobin, leukocytes and platelets, changes in the levels of serum glutamate oxaloacetate transaminase, serum glutamate pyruvate transaminase and prothrombin Time; changes in the levels of plasma creatinine, gastrointestinal effects (oral ulcers, diarrhea, nausea and vomiting), skin changes (rash, pruritus, and alopecia) and pulmonary effects (pneumonitis and pneumonia).

    Measured: In 72 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2012 (estimated)
  2. Study startApr 2013
  3. Primary completionAug 2014 (estimated)
  4. Study completionDec 2014 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01741558
Sponsor's protocol ID
UP 4747/12
Other IDs
CAAE 04482712.3.0000.5333
Acronym
TETHYS
Status last verified
Apr 2013
First submitted
3 Dec 2012
Last updated
9 Apr 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Moreira DM, Lueneberg ME, da Silva RL, Fattah T, Gottschall CAM. MethotrexaTE THerapy in ST-Segment Elevation MYocardial InfarctionS: A Randomized Double-Blind, Placebo-Controlled Trial (TETHYS Trial). J Cardiovasc Pharmacol Ther. 2017 Nov;22(6):538-545. doi: 10.1177/1074248417699884. Epub 2017 Mar 22.

    PubMed 28325070

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Methotrexate and Riboflavin in people with Myocardial Infarction, run by Instituto de Cardiologia do Rio Grande do Sul at 2 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Daniel M. Moreira, MSc. (554884175590, danielmedeirosmoreira@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area under the curve of creatine kinase (time frame: During 72 hours after the infarct). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01741558, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2013.

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